Latest From Elizabeth Orr
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.
The US HHS was responsible for the most major regulations over the last few years of any agency, an OMB report shows.
If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.
On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape.
Three attorneys got out their crystal balls to forecast what device industry sectors may come in for enforcement scrutiny related to the COVID-19 pandemic.
In a change from the draft, the final rule exempts device-specific regulations from scheduled review.